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©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  	
  	
  	
  	
  	
  
1	
  
Karl Schulmeisters - CTO
February, 2015	
  
Medical Device Innovator Support	
  
 	
  	
  	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  
2	
  
 	
  	
  	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  
3	
  
3
Current    -­‐  Inconsistent  Data  Sources
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Care	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  ConfidenBal:	
  Please	
  Do	
  Not	
  Copy	
  or	
  Distribute	
  
	
   4	
  
•  Over	
  a	
  Dozen	
  FDA	
  Databases	
  
•  HTML	
  	
  
•  Scanned	
  PDFs	
  
•  Centers	
  for	
  Medicare	
  Services	
  
•  Federal	
  and	
  State	
  
•  NaAonal	
  InsAtutes	
  of	
  Health	
  	
  
•  Clinical	
  Trials	
  Registry	
  
•  American	
  Materials	
  Standards	
  
•  BioMaterials	
  
•  Medical	
  Subjects	
  Headings	
  DicAonary	
  (MeSH	
  )	
  
Current    -­‐  Inconsistent  Data  Sources
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Care	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  ConfidenBal:	
  Please	
  Do	
  Not	
  Copy	
  or	
  Distribute	
  
	
   5	
  
•  Over	
  a	
  Dozen	
  FDA	
  Databases	
  
•  HTML	
  	
  
•  Scanned	
  PDFs	
  
•  Centers	
  for	
  Medicare	
  Services	
  
•  Federal	
  and	
  State	
  
•  NaAonal	
  InsAtutes	
  of	
  Health	
  	
  
•  Clinical	
  Trials	
  Registry	
  
•  American	
  Materials	
  Standards	
  
•  BioMaterials	
  
•  Medical	
  Subjects	
  Headings	
  DicAonary	
  (MeSH	
  )	
  
 	
  	
  	
  
©	
  Copyright	
  2014-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  
6	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  	
  	
  	
  	
  	
  
7	
  
ClearRoadmap  Solu7on
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  	
  	
  	
  	
  
8	
  
Pathways
We’ll	
  help	
  innovators	
  
uncover	
  the	
  steps	
  for	
  
pathways	
  	
  	
  
to	
  successfully	
  	
  
plan	
  and	
  execute	
  
Idea	
  to	
  Market	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  .	
  	
  	
  	
  	
  
9	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  	
  	
  	
  	
  	
  
10	
  
pply	
  filters	
  to	
  secAons	
  
of	
  document	
  
and	
  	
  
Medical	
  Specialty	
  
	
  
o	
  Zoom	
  in	
  on	
  Specific	
  
usage	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  
11	
  
Customized  alerts  

Use	
  our	
  system	
  to	
  tailor	
  alerts	
  	
  
to	
  your	
  specific	
  preferences	
  	
  
to	
  track	
  changes	
  	
  
within	
  the	
  medical	
  device	
  
approvals,	
  recalls	
  and	
  
warnings.	
  
Just	
  choose	
  the	
  devices,	
  markets	
  and	
  acAons	
  you’re	
  interested	
  in	
  monitoring,	
  and	
  we’ll	
  deliver	
  
personalized,	
  comprehensive	
  and	
  real-­‐Ame	
  alerts	
  directly	
  to	
  your	
  Twi`er	
  feed	
  or	
  email	
  inbox.	
  
•  mHealth	
  Innovators	
  who	
  want	
  to	
  sell	
  in	
  the	
  USA	
  
•  Get	
  our	
  free	
  Ideas	
  To	
  Market	
  guide	
  
•  Get	
  our	
  free	
  Checklist	
  	
  to	
  start	
  
•  Medical	
  Device	
  Innovators	
  who	
  want	
  to	
  sell	
  in	
  the	
  USA	
  
•  Use	
  Pathways	
  to	
  idenAfy	
  issues	
  
•  Use	
  Search	
  to	
  Find	
  ExisAng	
  devices	
  
•  Use	
  Reimbursement	
  to	
  develop	
  strategy	
  
•  Medical	
  Device	
  Consultants	
  
•  Improve	
  the	
  speed	
  and	
  quality	
  of	
  services	
  you	
  deliver	
  
•  Investors	
  
•  Get	
  be`er	
  insight	
  into	
  what	
  you	
  are	
  invesAng	
  in	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  
12	
  
Who  Should  Care?
Management  Team
•  Vizma	
  Carver,	
  Founder	
  and	
  CEO	
  
•  FDA	
  Entrepreneur-­‐in-­‐Residence	
  co-­‐leading	
  the	
  effort	
  to	
  rebalance	
  
pre-­‐	
  and	
  post-­‐market	
  data	
  requirements.	
  	
  
•  Implemented	
  the	
  first	
  and	
  only	
  standards-­‐based,	
  integrated,	
  
worldwide	
  Electronic	
  Medical	
  Records	
  system	
  within	
  the	
  Department	
  
of	
  Defense	
  (DoD).	
  
•  Led	
  the	
  development	
  of	
  outcomes-­‐based	
  funding	
  for	
  health	
  services	
  
and	
  Health	
  InformaAon	
  Technology.	
  
•  Karl	
  Schulmeisters,	
  CTO	
  
•  30	
  years	
  of	
  IT	
  experience	
  across	
  a	
  broad	
  range	
  of	
  industries	
  and	
  
companies	
  including	
  Microsof,	
  Nike,	
  Boeing,	
  Mitsubishi,	
  	
  Dubai	
  Water	
  
and	
  Electric	
  Authority	
  
•  Director	
  of	
  SoluAons	
  Architecture	
  in	
  the	
  CTO	
  Office	
  of	
  Unisys	
  
•  Microsof	
  Industry	
  Strategist	
  
•  Corbis	
  –	
  Sofware	
  Systems	
  Architect	
  
•  Delivered	
  soluAons	
  from	
  Cloud	
  CompuAng	
  and	
  Big	
  Data	
  to	
  mobile	
  
consumer	
  devices	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Care	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  ConfidenBal:	
  Please	
  Do	
  Not	
  Copy	
  or	
  Distribute	
  
	
  
•  mHealth,	
  fitness	
  Startups:	
  	
  
•  h`ps://ClearRoadmap.com	
  	
  
•  Free	
  From	
  Idea	
  to	
  Market	
  
•  Free	
  mHealth	
  Checklist	
  
•  Discounted	
  2	
  Week	
  Trial	
  
•  Launch	
  Partners	
  
•  15%	
  discount	
  for	
  any	
  packages	
  purchased	
  in	
  February	
  and	
  March	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  
14	
  
Call  To  Ac7on
h`ps://ClearRoadmap.com	
  	
  
h`p://twi`er.com/@ClearRoadmap	
  	
  
h`ps://www.facebook.com/pages/Clearroadmap/581029671954902	
  	
  
	
  
©	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  
15	
  

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  • 2.         ©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.         2  
  • 3.         ©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.         3   3
  • 4. Current    -­‐  Inconsistent  Data  Sources ©  Copyright  2013-­‐2015  Carver  Global  Health  Care  LLC.    All  rights  Reserved.          ConfidenBal:  Please  Do  Not  Copy  or  Distribute     4   •  Over  a  Dozen  FDA  Databases   •  HTML     •  Scanned  PDFs   •  Centers  for  Medicare  Services   •  Federal  and  State   •  NaAonal  InsAtutes  of  Health     •  Clinical  Trials  Registry   •  American  Materials  Standards   •  BioMaterials   •  Medical  Subjects  Headings  DicAonary  (MeSH  )  
  • 5. Current    -­‐  Inconsistent  Data  Sources ©  Copyright  2013-­‐2015  Carver  Global  Health  Care  LLC.    All  rights  Reserved.          ConfidenBal:  Please  Do  Not  Copy  or  Distribute     5   •  Over  a  Dozen  FDA  Databases   •  HTML     •  Scanned  PDFs   •  Centers  for  Medicare  Services   •  Federal  and  State   •  NaAonal  InsAtutes  of  Health     •  Clinical  Trials  Registry   •  American  Materials  Standards   •  BioMaterials   •  Medical  Subjects  Headings  DicAonary  (MeSH  )  
  • 6.         ©  Copyright  2014-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.         6  
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  • 11. ©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.           11   Customized  alerts   Use  our  system  to  tailor  alerts     to  your  specific  preferences     to  track  changes     within  the  medical  device   approvals,  recalls  and   warnings.   Just  choose  the  devices,  markets  and  acAons  you’re  interested  in  monitoring,  and  we’ll  deliver   personalized,  comprehensive  and  real-­‐Ame  alerts  directly  to  your  Twi`er  feed  or  email  inbox.  
  • 12. •  mHealth  Innovators  who  want  to  sell  in  the  USA   •  Get  our  free  Ideas  To  Market  guide   •  Get  our  free  Checklist    to  start   •  Medical  Device  Innovators  who  want  to  sell  in  the  USA   •  Use  Pathways  to  idenAfy  issues   •  Use  Search  to  Find  ExisAng  devices   •  Use  Reimbursement  to  develop  strategy   •  Medical  Device  Consultants   •  Improve  the  speed  and  quality  of  services  you  deliver   •  Investors   •  Get  be`er  insight  into  what  you  are  invesAng  in   ©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.           12   Who  Should  Care?
  • 13. Management  Team •  Vizma  Carver,  Founder  and  CEO   •  FDA  Entrepreneur-­‐in-­‐Residence  co-­‐leading  the  effort  to  rebalance   pre-­‐  and  post-­‐market  data  requirements.     •  Implemented  the  first  and  only  standards-­‐based,  integrated,   worldwide  Electronic  Medical  Records  system  within  the  Department   of  Defense  (DoD).   •  Led  the  development  of  outcomes-­‐based  funding  for  health  services   and  Health  InformaAon  Technology.   •  Karl  Schulmeisters,  CTO   •  30  years  of  IT  experience  across  a  broad  range  of  industries  and   companies  including  Microsof,  Nike,  Boeing,  Mitsubishi,    Dubai  Water   and  Electric  Authority   •  Director  of  SoluAons  Architecture  in  the  CTO  Office  of  Unisys   •  Microsof  Industry  Strategist   •  Corbis  –  Sofware  Systems  Architect   •  Delivered  soluAons  from  Cloud  CompuAng  and  Big  Data  to  mobile   consumer  devices   ©  Copyright  2013-­‐2015  Carver  Global  Health  Care  LLC.    All  rights  Reserved.          ConfidenBal:  Please  Do  Not  Copy  or  Distribute    
  • 14. •  mHealth,  fitness  Startups:     •  h`ps://ClearRoadmap.com     •  Free  From  Idea  to  Market   •  Free  mHealth  Checklist   •  Discounted  2  Week  Trial   •  Launch  Partners   •  15%  discount  for  any  packages  purchased  in  February  and  March   ©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.           14   Call  To  Ac7on h`ps://ClearRoadmap.com     h`p://twi`er.com/@ClearRoadmap     h`ps://www.facebook.com/pages/Clearroadmap/581029671954902      
  • 15. ©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved   15